Fasikl to Present Late-breaking Results From the Pivotal TRANQUIL Study of the Felix NeuroAI Wristband at the 2025 American Academy of Neurology Annual Meeting

Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that results from the TRANQUIL pivotal study evaluating the efficacy and safety of the Felix^TM NeuroAI^TM Wristband in patients with essential tremor (ET) will be presented at the Late-breaking Science session during the upcoming 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego on April 8, 2025.

Presentation details include:

• Title: TRANQUIL: Pivotal Study of the Felix NeuroAI Wristband in Patients with Essential Tremor
• Date: Tuesday, April 8, 2025
• Time: 06:09 PM - 06:15 PM PDT
• Location: San Diego Convention Center | 6A

“The TRANQUIL study represents a significant milestone in the pursuit of safe, non-invasive treatments for individuals living with essential tremor,” said Zhi Yang, Ph.D., CEO of Fasikl. “Felix is a groundbreaking advancement in AI therapeutics with the potential to revolutionize disease treatment. If approved, our technology will provide both patients and physicians with a new treatment option. The comprehensive results from the randomized, sham-controlled, double-blind study validate its efficacy and safety. We are excited to share the full results at the AAN meeting and discuss the impact on the future of essential tremor and movement disorder treatments.”

About the TRANQUIL Pivotal Study

The TRANQUIL study, a randomized, double-blind, sham-controlled clinical trial, enrolled 125 adults across 12 clinical sites in the U.S. and China. Participants were randomized 2:1 to receive either the Felix™ NeuroAI™ Wristband or a sham device and wore it during waking hours for 90 days. The study’s primary endpoint was change in the modified Activities of Daily Living (mADL) score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS), a commonly used tremor assessment that combines 10 activities of daily living (ADLs) and 2 clinical assessments of tremor.¹ The mADL has a maximum score of 52.

About Essential Tremor (ET)

Essential tremor (ET) is the most common type of tremor disorder, affecting approximately 7 million people in the United States.² It causes involuntary, rhythmic shaking, most often in the hands, which can make everyday activities like drinking from a glass or tying shoelaces difficult.³ Over time, ET can worsen and significantly impact a person’s quality of life.³

About the Felix™ NeuroAI™ Wristband*

The Felix™ NeuroAI™ Wristband is an AI-powered, non-invasive investigational wearable designed to provide all-day relief for individuals living with essential tremor (ET). Felix™ introduces AI to continuously adjust the stimulation, offering personalized and dynamic therapy that improves treatment outcomes over time. Unlike surgical interventions, Felix™ provides a non-invasive solution in the form of a comfortable wristband. It also seamlessly connects to Fasikl’s AI cloud platform, enabling continuous data integration to refine its algorithm and further optimize treatment for each user.

About Fasikl

Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl’s portfolio, currently under FDA review, includes the Felix™ NeuroAI™ Wristband and the MindForce™ Nerve-Computer Interface. To learn more, visit fasikl.com.

*Currently not FDA approved.

References:

1. Elble R, Comella C, Fahn S, Hallett M, Jankovic J, Juncos JL, Lewitt P, Lyons K, Ondo W, Pahwa R, Sethi K, Stover N, Tarsy D, Testa C, Tintner R, Watts R, Zesiewicz T. Reliability of a new scale for essential tremor. Mov Disord. 2012 Oct;27(12):1567-9.
2. Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data. Tremor Other Hyperkinet Mov (N Y). 2014;4:259. https://doi.org/10.7916/D8TT4P4B
3. Mayo Foundation for Medical Education and Research. (2025, March 15). Essential tremor. Mayo Clinic.https://www.mayoclinic.org/diseases-conditions/essential-tremor/symptoms-causes/syc-20350534

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